Displaying publications 1 - 20 of 25 in total

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  1. Ting CY, Adruce SAZ, Hassali MA, Ting H, Lim CJ, Ting RS, et al.
    Trials, 2019 05 10;20(1):267.
    PMID: 31077233 DOI: 10.1186/s13063-019-3348-x
    After publication of the original article [1], the authors have notified us that there are changes to the primary outcome of the study, instrument, subject's inclusion criteria, the funding and acknowledgements. These changes were made during the recruitment of participants and after approved by the Medical Research and Ethics Committee (MREC), National Institutes of Health Malaysia, on 16th November 2018.
    Matched MeSH terms: Ethics Committees, Research
  2. Kaur S, Balan S
    Theor Med Bioeth, 2015 Oct;36(5):341-61.
    PMID: 26438122 DOI: 10.1007/s11017-015-9339-3
    The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards (IRBs) were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest (CIs) faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection.
    Matched MeSH terms: Ethics Committees, Research/standards; Ethics Committees, Research/trends; Ethics Committees, Research/ethics*
  3. Ng SC, Kaplan GG, Tang W, Banerjee R, Adigopula B, Underwood FE, et al.
    Am J Gastroenterol, 2019 01;114(1):107-115.
    PMID: 30177785 DOI: 10.1038/s41395-018-0233-2
    INTRODUCTION: Living in an urban environment may increase the risk of developing inflammatory bowel disease (IBD). It is unclear if this observation is seen globally. We conducted a population-based study to assess the relationship between urbanization and incidence of IBD in the Asia-Pacific region.

    METHODS: Newly diagnosed IBD cases between 2011 and 2013 from 13 countries or regions in Asia-Pacific were included. Incidence was calculated with 95% confidence interval (CI) and pooled using random-effects model. Meta-regression analysis was used to assess incidence rates and their association with population density, latitude, and longitude.

    RESULTS: We identified 1175 ulcerative colitis (UC), 656 Crohn's disease (CD), and 37 IBD undetermined (IBD-U). Mean annual IBD incidence per 100 000 was 1.50 (95% CI: 1.43-1.57). India (9.31; 95% CI: 8.38-10.31) and China (3.64; 95% CI, 2.97-4.42) had the highest IBD incidence in Asia. Incidence of overall IBD (incidence rate ratio [IRR]: 2.19; 95% CI: 1.01-4.76]) and CD (IRR: 3.28; 95% CI: 1.83-9.12) was higher across 19 areas of Asia with a higher population density. In China, incidence of IBD (IRR: 2.37; 95% CI: 1.10-5.16) and UC (IRR: 2.63; 95% CI: 1.2-5.8) was positively associated with gross domestic product. A south-to-north disease gradient (IRR: 0.94; 95% CI: 0.91-0.98) was observed for IBD incidence and a west-to-east gradient (IRR: 1.14; 95% CI: 1.05-1.24) was observed for CD incidence in China. This study received IRB approval.

    CONCLUSIONS: Regions in Asia with a high population density had a higher CD and UC incidence. Coastal areas within China had higher IBD incidence. With increasing urbanization and a shift from rural areas to cities, disease incidence may continue to climb in Asia.

    Matched MeSH terms: Ethics Committees, Research
  4. Naqvi AA, Mahmoud MA, AlShayban DM, Alharbi FA, Alolayan SO, Althagfan S, et al.
    Saudi Pharm J, 2020 Sep;28(9):1055-1061.
    PMID: 32922135 DOI: 10.1016/j.jsps.2020.07.005
    Purpose: The study aimed to translate and validate the Arabic version of General Medication Adherence Scale (GMAS) in Saudi patients with chronic diseases.

    Methods: A multi-center cross sectional study was conducted for a month in out-patient wards of hospitals in Khobar, Dammam, Makkah, and Madinah, Saudi Arabia. Patients were randomly selected from a registered patient pools at hospitals and the item-subject ratio was kept at 1:20. The tool was assessed for factorial, construct, convergent, known group and predictive validities as well as, reliability and internal consistency of scale were also evaluated. Sensitivity, specificity, and accuracy were also evaluated. Data were analyzed using SPSS v24 and MedCalc v19.2. The study was approved by concerned ethics committees (IRB-129-25/6/1439) and (IRB-2019-05-002).

    Results: A total of 282 responses were received. The values for normed fit index (NFI), comparative fit index (CFI), Tucker Lewis index (TLI) and incremental fit index (IFI) were 0.960, 0.979, 0.954 and 0.980. All values were >0.95. The value for root mean square error of approximation (RMSEA) was 0.059, i.e., <0.06. Hence, factorial validity was established. The average factor loading of the scale was 0.725, i.e., >0.7, that established convergent validity. Known group validity was established by obtaining significant p-value <0.05, for the associations based on hypotheses. Cronbach's α was 0.865, i.e., >0.7. Predictive validity was established by evaluating odds ratios (OR) of demographic factors with adherence score using logistic regression. Sensitivity was 78.16%, specificity was 76.85% and, accuracy of the tool was 77.66%, i.e., >70%.

    Conclusion: The Arabic version of GMAS achieved all required statistical parameters and was validated in Saudi patients with chronic diseases.

    Matched MeSH terms: Ethics Committees, Research
  5. Bakrin FS, Makmor-Bakry M, Che Hon WH, Faizal SM, Manan MM, Ming LC
    Pharmacy (Basel), 2020 Dec 08;8(4).
    PMID: 33302438 DOI: 10.3390/pharmacy8040235
    INTRODUCTION: Drug utilization of analgesics in a private healthcare setting is useful to examine their prescribing patterns, especially the newer injectable cyclooxygenase (COX)-2 inhibitors (coxibs).

    OBJECTIVES: To evaluate the utilization of coxibs and traditional nonsteroidal anti-inflammatory drugs (tNSAIDs) indicated for postoperative orthopaedic pain control using defined daily dose (DDD) and ratio of use density to use rate (UD/UR).

    METHOD: A retrospective drug utilization review (DUR) of nonsteroidal anti-inflammatory drugs (NSAIDs) at an inpatient department of a private teaching hospital in Seremban, Malaysia was conducted. Patients' demographic characteristics, medications prescribed, clinical lab results, visual analogue scale (VAS) pain scores and length of hospital stay were documented. Orthopaedic surgeries, namely arthroscopy, reconstructive, and fracture fixation, were included. Stratified random sampling was used to select patients. Data were collected through patients' medical records. The DDD per 100 admissions and the indicator UD/UR were calculated with the World Health Organization's DDD as a benchmark. The inclusion criteria were patients undergoing orthopaedic surgery prescribed with coxibs (celecoxib capsules, etoricoxib tablets, parecoxib injections) and tNSAIDs (dexketoprofen injections, diclofenac sodium tablets). Data were analysed descriptively. This research was approved by the academic institution and the hospital research ethics committee.

    RESULT: A total of 195 records of patients who received NSAIDs were randomly selected among 1169 cases. In term of the types of orthopaedic surgery, the ratio of included records for arthroscopy:fracture fixation:reconstructive surgery was 55.4:35.9:8.7. Most of the inpatients had low rates of common comorbidities such as cardiovascular disease as supported by their baseline parameters. The majority were not prescribed with other concomitant prescriptions that could cause drug interaction (74.9%), or gastroprotective agents (77.4%). Overall, DDDs per 100 admissions for all NSAIDs were less than 100, except for parecoxib injections (389.23). The UD/UR for all NSAIDs were less than 100, except for etoricoxib tablets (105.75) and parecoxib injections (108.00).

    DISCUSSION: As per guidelines, the majority (96.9%) received other analgesics to ensure a multimodal approach was carried out to control pain. From the UD/UR results, the arthroscopy surgery was probably the most appropriate in terms of NSAID utilization.

    CONCLUSION: The prescribing pattern of NSAIDs except parecoxib was appropriate based on adverse effect and concurrent medication profile. The findings of this DUR provide insight for a low-risk patient population at a private specialized teaching hospital on the recommended use of NSAIDs for postoperative orthopaedic pain control.

    Matched MeSH terms: Ethics Committees, Research
  6. Croci DM, Dalolio M, Aghlmandi S, Taub E, Rychen J, Chiappini A, et al.
    Neurol Res, 2021 Jan;43(1):40-53.
    PMID: 33106124 DOI: 10.1080/01616412.2020.1819091
    Objective: Early permanent cerebrospinal fluid (CSF) diversion for hydrocephalus during the first 2 weeks after aneurysmal subarachnoid hemorrhage (aSAH) shortens the duration of external ventricular drainage (EVD) and reduces EVD-associated infections (EVDAI). The objective of this study was to detect any association with symptomatic delayed cerebral vasospasm (DCVS), or delayed cerebral ischemia (DCI) by the time of hospital discharge. Methods: We used a single-center dataset of aSAH patients who had received a permanent CSF diversion. We compared an 'early group' in which the procedure was performed up to 14 days after the ictus, to a 'late group' in which it was performed from the 15th day onward. Results: Among 274 consecutive aSAH patients, 39 (14%) had a permanent CSF diversion procedure with a silver-coated EVD. While the blood clot burden was similarly distributed, patients with early permanent CSF diversion (20 out of 39; 51%) had higher levels of consciousness on admission. Early permanent CSF diversion was associated with less colonized catheter, a shorter duration of extracorporeal CSF diversion (OR 0.73, 95%CI 0.58-0.92 per EVD day), and a lower rate of EVDAI (OR 0.08, 95%CI 0.01-0.80). The occurrence of CSF diversion device obstruction, the rate of symptomatic DCVS or detected DCI on computed tomography and the likelihood of a poor outcome at discharge did not differ between the two groups. Discussion: Early permanent CSF diversion lowers the occurrence of catheter colonization and infectious complication without affecting DCVS-related morbidity in good-grade aSAH patients. These findings need confirmation in larger prospective multicenter cohorts. Abbreviations: aSAH: aneurysmal subarachnoid hemorrhage; BNI: Barrow Neurological Institute Scale; CSF: Cerebrospinal fluid; DCVS: Delayed Cerebral Vasospasm; DCI: Delayed Cortical Ischemia; EKNZ: Ethik-Kommission Nordwest Schweiz; EVD: External ventricular drain; EVDAI: External ventricular drain-associated infections; GCS: Glasgow Coma Scale; IRB: Institutional Review Board; IVH: Inraventricular hemorrhage; mRS: Modified Rankin Scale; SOS: Swiss Study of Subarachnoid Hemorrhage Registry; WFNS: World Federation Neurological-Surgeon Scale.
    Matched MeSH terms: Ethics Committees, Research
  7. Mohd Said Nurumal, Mohammad Syafiq Mohamad Azizi, Muhammad Kamil Che Hasan
    MyJurnal
    Introduction: Simulation is widely practiced as learning strategies in many disciplines including nursing. It is con- sidered an updated technological approach towards providing safe and sound patients care. Thus, this study was conducted to assess the level of knowledge among nursing students using a simulated mannequin for cardiovascular assessment. Methods: This is a cross-sectional study design focusing Year 4 nursing students at Kulliyyah of Nurs- ing, International Islamic University Malaysia (IIUM). A simulation mannequin was used for students performing a cardiovascular assessment. Level of knowledge was tested using an adapted questionnaire. The study was approved by the Kulliyyah of Nursing Postgraduate Research Committee (Ref: IIUM/313/DDAA/20/4/10) and IIUM Research Ethics Committee (Ref: IREC 2018-024). Results: A total of 57 nursing students involved in this study revealing good cardiovascular assessment knowledge. Majority of them reported that simulation exercise is one of the good learning strategies to enhance their capabilities and increase their confidence level. Conclusions: The results from this study could indicate that using technological simulation approach could provide a similar effect in performing cardiovas- cular assessment among nursing student IIUM. Future larger scale is needed including for any other disciplines in nursing to facilitate students’ preparation towards the real clinical setting.

    Matched MeSH terms: Ethics Committees, Research
  8. Segaran Ramodran, Billy Bryan Jafrin, Mellonna Ignatia Jeffrey Liew, Nurul MadihahMohd Raeh, Juecella Joyce Jalius
    MyJurnal
    Introduction: EC1773 is a community outreach program conducted annually by Universiti Malaysia Sabah (UMS). It serves as a platform for nursing and medical students to collaborate hands-on health promotion for rural commu- nities. As of date, there has been no empirical study to gauge student`s post-program satisfaction. This study aims to evaluate satisfaction among students who have undergone the UMS-led community out-reach program and identify gaps for improvement. Methods: The study entailed a cross-sectional design involving 165 (N) nursing(n=65) and medical students (n=100) who had completed a 10-day rural outreach program. Ethical approval was obtained from the Research Ethics Committee of UMS as well-informed consent from respondents. A 25- item questionnaire requir- ing Likert-scale responsewas used to evaluatethe level of satisfaction across 5 sub-categories namely; pre-departure preparation & briefing;onsite facilities and logistics; teamwork; community participation and learning achievements. Results: Among 165 nursing -medical students in the study, 88% (n=146) were satisfied and 12% (n=19) were dis- satisfied with the UMS-led outreach program. Sub-category items rated as satisfactory were community participation 96% and learning achievements 91%. Poor satisfaction highlighted by respondents regarding the out-reach program were inadequacy of facilities and poor logistics 62% and quality of pre-departure preparation and briefing 66%. Nursing students reported significantly higher dissatisfaction (p=0.04) regarding teamwork and adequacy of onsite facilities and logistics. Conclusion: Findings from this study infers that student’s post-evaluation towards the UMS-led outreach is generally satisfactory but has specific shortfalls that need to be addressed.
    Matched MeSH terms: Ethics Committees, Research
  9. Segaran Ramodran, Lenny Seputri Masse, Nurul Hanis Syazwan Irawan, Suhailah Saniman
    MyJurnal
    Introduction: Smartphone has become an essential Smart-tool for IT-based learning among university students. How- ever, excessive use of smartphones can be addictive leading to psychological distress, poor academic performance, social isolation and depression. In the context of University Malaysia Sabah (UMS), the issue of contention is whether smartphone addiction is a problem among nursing undergraduate students and thus the justification for this study. This study evaluated the pattern of usage smartphone and addiction among nursing students in UMS. Methods: The study deployed a cross-sectional survey design involving 100 (N) respondents selected through clustered convenient sampling from year 1(n=35), year 2 (n=35) and year 3 (n=30) nursing students who are currently pursuing their di- ploma study in UMS. Ethical approval was obtained from the Research Ethics Committee of UMS as well-informed consent from respondents. The study tool consisted of a well-establish validated questionnaire benchmarked from a previous study (reliability Cronbach α= 0.78) which captured respondents’ socio-demographics, smartphone us- age characteristic proforma and Smart Addiction Scale (SAS). Results: Among 100 nursing students in this study, 78% (n=78) of them had high smartphone usageaveraging 4.3 hours daily. The overall prevalence of smartphone addiction among nursing students in this study was 25% (n=25). Male student nurses significantly had higher smart- phone addiction scores compared to female students (p=0.01). Likewise, year 3 students had higher addiction scores compared to their peers in year 2 or year 1 (p=0.002). Conclusion: findings from this study imply that smartphone addiction affects 1 in 4 nursing students in UMS and there is a need to develop ‘digital detox” strategies to address the issue.
    Matched MeSH terms: Ethics Committees, Research
  10. Kaur S
    J Med Ethics, 2013 Apr;39(4):230.
    PMID: 23077337 DOI: 10.1136/medethics-2012-100965
    Matched MeSH terms: Ethics Committees, Research*
  11. See HY, Mohamed MS, Nor SNM, Low WY
    J Empir Res Hum Res Ethics, 2021 12;16(5):487-500.
    PMID: 34292842 DOI: 10.1177/15562646211033191
    Empirical evidence of the ethical review of clinical and biomedical research in Malaysia is limited. We have conducted a convergent mixed methods research, which comprises an online survey and semistructured interviews to examine the challenges in the ethical review of clinical and biomedical research. Data collected reveal that the ethics review process is inconsistent, duplicate, and inadequate. The results indicate a strong need for a centralized ethical review mechanism and a national system for mutual recognition of ethics reviews to improve the effectiveness and efficiency of the ethics review system in Malaysia. A joint research ethics committee review between Malaysia and sponsoring countries for multinational research should also be encouraged as it could address the concerns of the lack of expertise and training.
    Matched MeSH terms: Ethics Committees, Research
  12. Mak, Joon-Wah
    MyJurnal
    The International Medical University (IMU) has encouraged and facilitated research activities since 2001. Research activities by undergraduates, postgraduates, and faculty members have increased substantially since then. The governance aspects of research activities are closely monitored by the Institutional Review Board which is the IMU-Joint Committee on Research and Ethics. (Copied from article)
    Matched MeSH terms: Ethics Committees, Research
  13. Nor Dalila Marican, Rozita Hod, Nadiah Wan-Arfah, Azmi Hassan
    Int J Public Health Res, 2018;8(1):933-938.
    MyJurnal
    Introduction Non-specific low back pain is one of the most common physical ailments
    affecting millions of people worldwide. This condition constitutes a
    significant public health problem and was listed as a prevalent health
    complaint in most societies. Even though there are many anecdotal claims
    for reflexology in the treatment of various conditions such as a migraine,
    arthritis and multiple sclerosis, but very little clinical evidence exists for
    reflexology on the management of low back pain per se. This study aims to
    evaluate the effects of foot reflexology therapy as an adjunctive treatment to
    the Malaysian low back pain standard care in relieving pain and promoting
    health-related quality of life among people with non-specific low back pain.
    Methods This is a parallel randomized controlled trial with pre and post-treatment
    study design. The study setting for the intervention located at Penawar
    Reflexology Center, Kuala Terengganu, Malaysia. A total of 100
    participants with non-specific low back pain will be allocated to one of two
    groups, using a randomization computer program of Research Randomizer.
    The control group will receive low back pain standard care, while the
    intervention group will receive standard care plus eight sessions of foot
    reflexology therapy. The pain intensity and health-related quality of life
    scores will be measured using Visual Analogue Scale and Euro-quality of
    life scale respectively in both groups. The study was approved by the
    Human Research Ethics Committee of University Sultan Zainal Abidin
    (UHREC/2016/2/011). The study protocol was registered at
    ClinicalTrials.gov, with the ID number of NCT02887430.
    Measurements Outcome measures will be undertaken at pre-intervention (week 1), postintervention
    (week 6) and follow-up (week 10).
    Conclusions This will be the first trial to compare the foot reflexology therapy with
    control group among people who medically diagnosed with non-specific low
    back pain in Malaysia. The result of this study will contribute to better
    management of this population, especially for Malaysia healthcare setting.

    Study site: Penawar Reflexology Center, Kuala Terengganu, Malaysia
    Matched MeSH terms: Ethics Committees, Research
  14. Asma A, Azmi MN, Mazita A, Marina MB, Salina H, Norlaila M
    PMID: 22468245 DOI: 10.1007/s12070-011-0132-y
    Neuropathy is frequently a late complication of diabetes mellitus. Auditory neuropathy and microangiopathy of inner ear are the possible causes of hearing loss in diabetics. To study the correlation between glycaemic control and hearing threshold in patients with type 2 diabetes mellitus and to determine the differences of hearing threshold between groups treated with different modality. This single blind randomized controlled study was performed at the Department of Medicine and Department of Otorhinolaryngology, Hospital Universiti Kebangsaan Malaysia (UKM) between 1st May 2003 and 31st September 2004. This study was approved by Research Ethics Committee (code number FF-137). Subjects were randomized into two groups. Group 1 were patients treated with conventional oral hypoglycemic agents. The patients in group 2 were those treated with insulin injection. The subjects were seen 4 weekly for 3 months. Audiometric test were performed in all subjects at each visit. Blood were taken for fasting blood glucose, Hb1Ac, and fructosamine at every visit to determine the glycaemic controls of the subject. They were 11 patients (22 ears) treated with oral hypoglycemic agents and 17 patients treated (34 ears) with subcutaneous insulin. There is no significant difference between mean pure tone threshold before and after treatment at all frequencies in both groups. There is also no significance different in fasting glucose level and fructosamine. However, there is significant difference HbA1c levels between the two groups after treatment (P 
    Matched MeSH terms: Ethics Committees, Research
  15. Asma A, Abdul Fatah AW, Hamzaini AH, Mazita A
    Indian J Otolaryngol Head Neck Surg, 2013 Dec;65(Suppl 3):526-31.
    PMID: 24427708 DOI: 10.1007/s12070-011-0438-9
    In managing patient with congenital congenital aural atresia (CAA), preoperative high resolution computed tomography (HRCT) scan and hearing assessment are important. A grading system based on HRCT findings was first introduced by Jahrsdoefer in order to select appropriate candidates for operation and to predict the postoperative hearing outcome in CAA patients. The score of eight and more was considered as a good prognostic factor for hearing reconstruction surgery. However previously in our center this score was not used as the criteria for surgical procedure. This study was conducted at Center A to evaluate the correlation between pre and postoperative hearing level with HRCT based on a Jahrsdoefer grading system in patients with CAA. All records and HRCT films with CAA from January 1997 until December 2007 at Center A were evaluated. The demographic data, operative records, pre and post operative hearing levels and HRCT findings were analyzed. Hearing level in this study was based on a pure tone average of air-bone gap at 500 Hz, 1 kHz and 2 kHz or hearing level obtained from auditory brainstem response eudiometry. This study was approved by Research Ethics Committee (code number, FF-197-2008). Thirty-two ears were retrospectively evaluated. The postoperative hearing level of 30 dB and less was considered as successful hearing result postoperatively. Of the six ears which underwent canalplasty, three had achieved successful hearing result. However, there was no significant correlation between preoperative hearing level (HL) with HRCT score and postoperative HL with HRCT score at 0.05 significant levels (correlation coefficient = -0.292, P = 0.105 and correlation coefficient = -0.127, P = 0.810) respectively. Hearing evaluation and HRCT temporal bone are two independent evaluations for the patients with CAA before going for hearing reconstructive surgery.
    Matched MeSH terms: Ethics Committees, Research
  16. AlShayban DM, Naqvi AA, Alhumaid O, AlQahtani AS, Islam MA, Ghori SA, et al.
    Front Pharmacol, 2020;11:60.
    PMID: 32153397 DOI: 10.3389/fphar.2020.00060
    Objective: The study aimed to evaluate the association between disease knowledge and medication adherence in patients with type 2 diabetes mellitus.

    Methods: A cross-sectional study was conducted for three months, in patients with type 2 diabetes who visited three community pharmacies located in Khobar, Saudi Arabia. Patients' disease knowledge and their adherence to medications were documented using Arabic versions of the Michigan Diabetes Knowledge Test and the General Medication Adherence Scale respectively. Data were analyzed through SPSS version 23. Chi-square test was used to report association of demographics with adherence. Spearman's rank correlation was employed to report the relationship among HbA1c values, disease knowledge and adherence. Logistic regression model was utilized to report the determinants of medication adherence and their corresponding adjusted odds ratio. Study was approved by concerned ethical committee (IRB-UGS-2019-05-001).

    Results: A total of 318 patients consented to participate in the study. Mean HbA1c value was 8.1%. A third of patients (N = 105, 33%) had high adherence and half of patients (N = 162, 50.9%) had disease knowledge between 51% - 75%. A significantly weak-to-moderate and positive correlation (ρ = 0.221, p < 0.01) between medication adherence and disease knowledge was reported. Patients with >50% correct answers in the diabetes knowledge test questionnaire were more likely to be adherent to their medications (AOR 4.46, p < 0.01).

    Conclusion: Disease knowledge in most patients was average and half of patients had high-to-good adherence. Patients with better knowledge were 4 to 5 times more likely to have high adherence. This highlights the importance of patient education and awareness regarding medication adherence in managing diabetes.

    Matched MeSH terms: Ethics Committees, Research
  17. Naqvi AA, AlShayban DM, Ghori SA, Mahmoud MA, Haseeb A, Faidah HS, et al.
    Front Pharmacol, 2019;10:633.
    PMID: 31231222 DOI: 10.3389/fphar.2019.00633
    Objective: The aim was to validate the General Medication Adherence Scale (GMAS) (English version) in Saudi patients with chronic disease. Methods: A month-long study was conducted in the out-patient department of tertiary care hospitals in three cities of Saudi Arabia that collected data from a randomized sample of Saudi patients with chronic disease. The study aimed to achieve an item-to-subject ratio greater than 1:10. Factor analyses were conducted and fit indices calculated. Convergent, discriminant, known group, and concurrent validities were analysed. Internal consistency was determined using test-retest reliability using Cronbach's alpha (α), McDonald's coefficient omega (ω
    t
    ), and Pearson's correlation coefficient (ρ). Sensitivity analysis was conducted. Data were analysed through Statistical Package for Social Sciences (SPSS) version 23. The study was ethically approved (i.e., IRB-129-26/6/1439). Results: The survey gathered responses from 171 patients with a response rate of 85.5%. An item-to-subject ratio of 1:15 was achieved. Factor analysis revealed a three-factor structure with acceptable fit indices (i.e., normed fit index (NFI) = 0.93, Tucker-Lewis index (TLI) = 0.99, and comparative fit index (CFI) = 0.99), i.e., greater than 0.9. The value of root mean square error of approximation (RMSEA) was 0.01, i.e., less than 0.08. The tool established construct validity, i.e., convergent and discriminant validities. Known group and concurrent validities were also established. An α value of 0.74 and ω
    t
    value of 0.92 were reported. Test-retest reliability ρ = 0.82, p < 0.001. The tool had high sensitivity (>75%) and specificity (>80%). Conclusion: The GMAS-English was successfully validated in Saudi patients with chronic disease.
    Matched MeSH terms: Ethics Committees, Research
  18. Yoshizawa G, Sasongko TH, Ho CH, Kato K
    Front Genet, 2017;8:99.
    PMID: 28775738 DOI: 10.3389/fgene.2017.00099
    The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases.
    Matched MeSH terms: Ethics Committees, Research
  19. Chin ARW, Chua YY, Chu MN, Mahadi NF, Yusof MSB, Wong MS, et al.
    MyJurnal
    Introduction: The academic life of medical students can be considered as psychological toxic. About half of United States medical students experience burnout and more than 25% experience depression. This study aimed to determine the prevalence of burnout among medical students in a Malaysian medical school and its associated factors.
    Methods: This is a cross sectional study of 452 medical students from Universiti Sains Malaysia (USM). Copenhagen Burnout Inventory was distributed via Google Forms through Facebook Messenger. Ethical approval was obtained from the Human Research Ethics Committee USM. Data were collected via Google Sheets. Each respondent only submitted one Google Form as no resubmission link was provided once completed Google Form was submitted.
    Result: The prevalence of burnout among USM medical students was 67.9%. Personal burnout was the highest (81.6%), followed by work-related burnout (73.7%) and client-related burnout (68.6%). The analysis showed that regardless of year of study, gender and ethnicity (all P > 0.05), USM medical students were vulnerable to burnout.
    Conclusion: The prevalence of burnout among USM medical students was high and the most prevalent type of burnout was personal burnout. Therefore, burnout among medical students should be a concern and must be addressed to prevent subsequent unwanted consequences.
    Matched MeSH terms: Ethics Committees, Research
  20. Kaur S, Choy CY
    Dev World Bioeth, 2014 Apr;14(1):20-8.
    PMID: 23170779 DOI: 10.1111/dewb.12004
    This article examines issues relating to ethics decision-making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH-GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH-GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles outlined in the ICH-GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH-GCP Guideline in its present form.
    Matched MeSH terms: Ethics Committees, Research*
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